Burns Clinical Trial - Sperry Micro-Coring System: Automated

Status Not yet recruiting

Clinical Trial Summary

The objective of this study is to validate the proof of concept regarding the approach of manual implantation of full-thickness skin microcolumns (FTSMs) into a dermal regeneration template as coverage for open wounds without creating an additional donor scar and while also capitalizing on the wound healing benefits offered by full-thickness skin grafts.

Clinical Trial Description

After enrollment and completion of informed consent, the patient will be considered an enrolled patient. Up to 10 patients with open wounds of the torso or extremities requiring skin grafting will be enrolled into this study. The study area will be 25 to 100 cm2. If a patient has multiple non-contiguous wounds that qualify for the study, up to two areas may be enrolled into the study. All other non-study areas will be treated per standard of care procedures/per the operating physician's discretion. The FTSMs will be harvested under sterile conditions in the operating room with a 1.5mm standard biopsy punch from a donor site deemed appropriate by the operating physician based on available healthy tissue; most commonly, the site is located on the thigh. Donor site location and rationale for this decision will be documented. Following FTSM harvest, they will be manually implanted into Integra® by experienced study personnel in the operating room. Using forceps, the FTSM will be inserted epidermis side up through the dermal regeneration matrix side with the silicone side being left in place. The FTSM within the dermal regeneration template will then be applied to the open wound and covered with a non-occlusive dressing. Additional secondary dressings of the physician's choice will also be utilized. Wounds will be assessed at the first dressing takedown while hospitalized by the subjects' medical teams and study members. Study members will be notified by hospital staff of any concerns including but not limited to infection, increased pain, or wound break-down. Study members will assess wounds at least once weekly for one month. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05223998
Study type	Interventional
Source	The Metis Foundation
Contact	Victoria Diaz, RN
Phone	2105691140
Email	diaz@metisfoundationusa.org
Status	Not yet recruiting
Phase	N/A
Start date	December 1, 2022
Completion date	September 29, 2024

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Sperry Micro-Coring System: Automated Full-Thickness Skin Microcolumns in Dermal Regeneration Templates for 'Donor-Free' Skin Renewal

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms